Novii+ Wireless Maternal and Fetal Monitoring Solution Cleared by the FDA for Monitoring Approximately 95% of All Eligible Births in the United States¹
- GE HealthCare receives FDA clearance for expanded indication for Novii+ maternal and fetal monitoring solution for pregnant patients ≥34 weeks.
- Novii+ noninvasively measures and displays fetal heart rate, maternal heart rate and uterine activity, while providing patient comfort and mobility in the hospital.
“Novii+ allows moms to move around and stay active during labor while providing reliable monitoring for their care teams,” said Lisa Allen, BSN, RN, senior clinical development specialist, maternal infant care, GE HealthCare. “This freedom of movement can help moms have a more comfortable labor experience.”
Novii+ is an expanded indication from the Novii Maternal and Fetal Monitoring Solution that utilizes an updated algorithm (Cross Check artifact reduction) to improve reliability and accuracy. Novii+ can be used for both antepartum and intrapartum pregnant patients 34 weeks and greater, which extends usage before the previously defined use of 37 weeks and greater of pregnancy. The expanded indication is based on data submitted to the FDA to determine Novii+ Wireless Patch Solution’s equivalence to doppler fetal heart rate, tocodynamometer uterine activity and pulse oximetry maternal heart rate devices for preterm patients (≥34 weeks) in terms of accuracy and reliability. In
Monitoring is crucial to check on health status for both pregnant patients and their fetuses particularly for preterm and high-risk pregnancies.3 Novii+ provides a personalized view of the mother and fetus’ statuses, and alerts care teams for changes to heart rate and contraction pattern during labor, so they can proactively intervene.
“One in ten newborns in
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1 Dr. Kurt R. Wharton is a paid consultant for GE HealthCare. The statements by Dr. Wharton described here are based on his own opinions and on results that were achieved in his unique setting. Since there is no “typical” hospital and many variables exist, i.e. hospital size, case mix, etc., there can be no guarantee that other customers will achieve the same results. |
Intrapartum monitoring provides care teams with the data needed to care for their patients confidently and efficiently.3 Nearly all respondents (
GE HealthCare designs solutions to meet the needs of providers, families, and patients to support care that can help send moms and babies home healthy. For more information on our fetal and maternal monitoring solutions, please visit: https://www.gehealthcare.com/products/maternal-infant-care/fetal-monitors
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1Natality, 2016-2022 expanded Request. Centers for Disease Control and Prevention. Group By: Plurality; OE Gestational Age Weekly. Accessed January 31, 2024.
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2Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15 ; (2) : CD003934 |
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3Ayres-de-Campos, D., Spong, C.Y., Chandraharan, E. and (2015), FIGO consensus guidelines on intrapartum fetal monitoring: Cardiotocography. International Journal of Gynecology & Obstetrics, 131: 13-24. https://doi.org/10.1016/j.ijgo.2015.06.020 |
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4Preterm birth. Centers for Disease Control and Prevention. October 24, 2023. Accessed December 29, 2023. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm |
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5Hoyert D. Maternal Mortality Rates in |
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Source: GE HealthCare